SHAPEABLE GUIDE CATHETERS AND RELATED METHODS

• US 20140330074A1
• Filed: 04/30/2014
• Published: 11/06/2014
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Morriss, John H., Pader, Mei
• Granted Patent: US 9,700,326 B2
• Time in Patent Office: Days
• US Class Current: 600/104
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/1657 Bone breaking devices
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/16 Bite blocks
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0012 : with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0053 : having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Shapeable guide catheters and methods for manufacturing and using such shapeable guide catheters. In one embodiment, the shapeable guide catheter comprises a tubular member having a shapeable region, a malleable shaping member attached to the shapeable region such that, when the shape of the shapeable region is changed from a first shape to a second shape, the shaping member will plastically deform to thereafter substantially hold the shapeable region in the second shape, a tubular outer jacket disposed about the outer surface of the tubular member and a tubular inner jacket disposed within the lumen of the tubular member. The shapeable region of the guide catheter may be manually formed into a desired shape before insertion of the guide catheter into the body. In some embodiments, the guide catheter is sized to be inserted through a nostril of a human patient and used to guide the transnasal insertion of another device (e.g., a guidewire, catheter, etc.) to a desired location within the nose, throat, ear or cranium of the subject.

Claims

1-49. -49. (canceled)

50. A method for dilating an opening in a head of a human or animal subject, the method comprising:

(a) bending a shapeable region of a shapeable guide member to a desired shape to facilitate advancement of a distal end of the guide member to a desired location, wherein the shapeable region is located closer to a distal end of the guide member than to a proximal end of the guide member, wherein the shapeable region substantially retains the desired shape after bending, wherein the act of bending is performed by a human operator;

(b) inserting the guide member, distal end first, into a head of the subject to position the distal end of the guide member at or near an opening in a paranasal sinus;

(c) advancing a balloon along the guide member to position the balloon within the paranasal sinus opening; and

(d) expanding the balloon within the paranasal sinus opening to break or remodel bone forming the opening and thereby dilate the opening.

51. The method of claim 50, wherein the guide member comprises a guide catheter, wherein the guide catheter defines a lumen.

52. The method of claim 51, wherein the act of advancing the balloon along the guide member comprises advancing the balloon through the lumen of the guide catheter.

53. The method of claim 50, wherein the act of advancing the balloon along the guide member comprises advancing a balloon catheter along the guide member, wherein the balloon is part of the balloon catheter.

54. The method of claim 50, wherein the shapeable region comprises a malleable material, wherein the act of bending comprises bending the malleable material.

55. The method of claim 50, wherein the opening in the paranasal sinus comprises a frontal sinus ostium, a sphenoid sinus ostium, or an opening into an ethmoid sinus.

56. The method of claim 50, wherein the opening in the paranasal sinus comprises a maxillary sinus ostium.

57. The method of claim 56, wherein the act of bending comprises bending the shapeable region in a curve configured to enable positioning of the distal end of the guide member through the middle meatus of the subject, around the uncinate process of the subject, and into the hiatus semilunaris of the subject, wherein the act of inserting the guide member comprises:

(i) inserting the guide catheter at a first rotational orientation to pass the distal end of the guide member by the middle turbinate of the subject, and

(ii) rotating the guide catheter to a second rotational orientation to hook the distal end of the guide member around the uncinate process of the subject.

58. The method of claim 50, wherein the act of bending comprises forming a curve in the shapeable region at a bend angle up to about 115 degrees.

59. The method of claim 58, wherein the act of bending comprises forming a curve in the shapeable region at a bend angle selected from the group consisting of:

approximately 30 degrees, approximately 70 degrees, approximately 90 degrees, and approximately 110 degrees.

60. The method of claim 50, further comprising forming the opening in the paranasal sinus.

61. The method of claim 50, further comprising advancing a guidewire through the guide member and into the paranasal sinus opening, wherein the act of advancing the balloon along the guide member further comprises advancing the balloon over the guidewire.

62. The method of claim 50, wherein the act of bending comprises using a bending tool, wherein the bending tool is configured to provide a preconfigured curve in the shapeable region of the guide member.

63. The method of claim 62, wherein the bending tool includes a plurality of bending features configured to provide different preconfigured curves in the shapeable region of the guide member, the method further comprising selecting a bending feature from the plurality of bending features.

64. The method of claim 50, further comprising securing an endoscope to the guide member via one or more connectors.

65. A method for dilating an opening in a head of a human or animal subject, the method comprising:

(a) bending a shapeable region of a shapeable guide member to a desired shape to facilitate advancement of a distal end of the guide member to a desired location, wherein the shapeable region is located closer to a distal end of the guide member than to a proximal end of the guide member, wherein the shapeable region substantially retains the desired shape after bending, wherein the act of bending is performed by a human operator;

(b) inserting the guide member, distal end first, into a head of the subject to position the distal end of the guide member at or near the opening in the head of the subject;

(c) advancing a balloon along the guide member to position the balloon within the opening in the head of the subject; and

(d) expanding the balloon within the opening in the head of the subject to thereby dilate the opening.

66. The method of claim 65, wherein the opening in the head of the subject comprises a paranasal sinus opening.

67. The method of claim 65, wherein the act of expanding the balloon comprises breaking or remodeling bone forming the opening.

68. The method of claim 65, wherein the opening in the head of the subject comprises a Eustachian tube.

69. A method for dilating an opening in a head of a human or animal subject, the method comprising:

(a) bending a shapeable region of a shapeable guide member to a desired shape to facilitate advancement of a distal end of the guide member to a desired location, wherein the shapeable region is located closer to a distal end of the guide member than to a proximal end of the guide member, wherein the shapeable region substantially retains the desired shape after bending, wherein the act of bending is performed by a human operator;

(b) securing an endoscope to the guide member via one or more connectors;

(c) inserting the guide member, distal end first, into a head of the subject to position the distal end of the guide member at or near the opening in the head of the subject;

(d) visualizing the distal end of the guide member with the endoscope;

(e) advancing a balloon along the guide member to position the balloon within the opening in the head of the subject; and

(f) expanding the balloon within the opening in the head of the subject to thereby dilate the opening.